Novartis nears remibrutinib filing for urticaria with new long-term data

Novartis is preparing to submit marketing applications for its BTK inhibitor, remibrutinib, in the treatment of chronic spontaneous urticaria (CSU) during the latter half of the year. This decision follows the recent release of long-term findings from two pivotal Phase III studies, with results set to be showcased at the upcoming European Academy of Allergy and Clinical Immunology (EAACI) congress.

The REMIX-1 and REMIX-2 trials were structured to compare the efficacy of twice-daily remibrutinib at a dose of 25 mg against a placebo in adults suffering from CSU that is not adequately managed by second-generation H1-antihistamines. Each trial included a substantial participant base, with 470 and 455 adults enrolled in REMIX-1 and REMIX-2, respectively. Initial results from August last year revealed that both studies successfully met their primary endpoints. They demonstrated significant and clinically meaningful reductions in disease activity as early as the second week of treatment.

The newly released 52-week data further substantiated these findings, showing marked improvements in weekly scores for urticaria activity (UAS7), itch severity (ISS7), and hive severity (HSS7) in patients treated with remibrutinib compared to those given a placebo. These benefits were consistent with earlier observations at the 12- and 24-week marks. Notably, more than half of the patients were entirely free from itch and hives by the 52nd week of treatment.

Interestingly, participants who initially received a placebo and were switched to remibrutinib at the 24-week point began showing positive responses within the first week after the transition. These beneficial effects continued throughout the remaining 28 weeks of the study.

Angelika Jahreis, the global head of development for immunology at Novartis, emphasized the significant impact of urticaria on patients' quality of life, stressing the urgent need for new treatment options. She highlighted that many patients suffering from moderate-to-severe CSU at the start of the study could achieve prolonged relief from their symptoms with remibrutinib.

Regarding safety, remibrutinib demonstrated a favorable profile over the 52-week period, with no serious adverse events attributed to the drug. Both the remibrutinib and placebo groups experienced similar increases in liver transaminases, and all such instances were asymptomatic, temporary, and reversible.

In April of the previous year, Novartis addressed concerns about potential liver toxicity, a known issue with other BTK inhibitors such as Merck KGaA’s evobrutinib, Sanofi’s tolebrutinib, and Roche’s fenebrutinib. Novartis confirmed that remibrutinib did not exhibit any signs of liver toxicity, further supporting its safety profile.

Beyond CSU, remibrutinib is being explored for its potential in treating other conditions, including hidradenitis suppurativa, where it achieved the primary endpoint in a Phase II trial. The drug is also being evaluated for use in food allergies, chronic inducible urticaria, and multiple sclerosis.

As Novartis moves forward with its plans to file marketing applications, the promising data from these extensive studies may soon translate into a new, much-needed treatment option for patients suffering from the debilitating effects of chronic spontaneous urticaria.